THREE-DIMENSIONAL MODELING

Course objectives

General objectives The general objective of the course is to provide the student: 1) the basic scientific and regulatory knowledge and formation that will allow him/her to find, comprehend and critically assess the data and documentation about biological drugs; 2) the basic knowledge about herbal drugs and the major challenges about their use. Specific objectives 1. Knowledge and comprehension by the student Knowledge of xenobiotic mechanisms of toxicity. Comprehension of the relationship between chemical properties and structure and mechanisms of toxicity. Knowledge of the factors influencing the variability in the response to a xenobiotic. Knowledge of toxicokinetics and pharmacokinetics; comprehension of their implications and applications in the pharmaceutical field. Knowledge on the methods of experimental studies. Comprehension of the risk evaluation process and its pharmaceutical applications. Knowledge of the basis of chemical carcinogenesis and developmental toxicity and the methods used for studying them. Knowledge of pharmacovigilance. 2. Ability in using knowledge and comprehension At the end of the course, the student should be able to: 1) find and critically evaluate scientific data about biological drugs and herbal drugs, also taking into account the current regulations; Al termine del corso lo studente dovrà essere in grado di: reperire e valutare criticamente le informazioni riguardanti farmaci biologici e piante medicinali, anche in relazione alla regolamentazione vigente; 2) comprehend the development process of new biological drugs. 3. Ability in examining and judging During the lessons, the teacher frequently questions the students in order to evaluate the comprehension and the ability to use the knowledge learnt. The students will be confronted with many cases of biological and herbal drugs upon which the students should express their evaluation. In the final test the student will expose to the teacher and other students a presentation on a biological drug and answer to questions on actual cases of herbal drugs. 4. Ability in communicating what learnt During the final presentation the student shold prove to be able to communicate exhaustively and concisely. 5. Ability in continuing the study autonomously The course aims to provide the formation giving the student the ability of evaluating critically the sources of information widely available, particularly in the web. During the course, the teacher will illustrate the main sources of reliable information, such as databases and sites of institutional organizations.

Channel 1
LUCA ROMANELLI Lecturers' profile

Program - Frequency - Exams

Course program
Biological medicines. Definition, pharmacological characteristics, examples, main therapeutic areas. Drug development. Experimental models. Assays for in vitro pharmacodynamic activity. Cellular, systemic, functional toxicity. Main mechanisms of cellular toxicity. Damage caused by the body's response. Inflammation and fibrosis. Co-exhibitions, interactions. Acute, chronic, delayed toxicity. Mechanisms of tolerance, rebound. Experimental toxicological studies. Duration of studies. Acute toxicity studies: purposes; lethality curves; acute exposure limits. Toxicity studies after repeated administration: doses, target organs, objectives. Safety pharmacology studies. Predictivity of animal studies. Doses used and extrapolation to humans. Limitations of toxicology studies for biological drugs, the relevant species. Chemical carcinogenesis. The multi-stage model of chemical carcinogenesis: initiation, promotion, progression. Definitions. IARC groups. Complete carcinogens, initiators, promoters, progression agents. Genotoxic and epigenetic carcinogens. Direct and indirect carcinogens. Epigenetic carcinogens: promoters, immunosuppressants. Animal carcinogenicity studies and interpretation problems. Genotoxicity studies; mutagenesis, clastogenesis tests, tests for other genetic damage, structure-activity relationship. Guidelines on genotoxicity studies for drugs. Use of drugs in pregnancy. Reproductive and developmental toxicology. Problems of identification and determination of 'safe' exposures. Critical periods of susceptibility: effects of exposure in the pre-implantation period, during organogenesis, and in the fetal period. Experimental studies. Information on the risk of using drugs in pregnancy. Medicines recognized as toxic for development. Regulatory classification of drugs based on developmental toxicity data. Pharmacokinetics. Aims of pharmacokinetic studies. Importance of drug metabolism for the elimination of activity; bioactivation. General mechanisms: passive diffusion, transporters; interactions at the level of transporters. Gastrointestinal absorption. Distribution. Routes of excretion. Kinetics of order I and order 0. Kinetic parameters and their uses. Pharmacokinetics of biological drugs (proteins). Routes of administration, mode of elimination. Formation of anti-drug antibodies and their clinical relevance. Biosimilar drugs. Synthetic drug metabolism. Purpose and effects on metabolism toxicity. Metabolism and pharmacological activity. General characteristics of biotransformation reactions. Multiple metabolic pathways. Variability of metabolizing enzymes. Genetic polymorphism of metabolizing enzymes. Interactions: enzyme induction and inhibition. Clinical trial. Phase 1, 2 and 3 studies. Aims of the studies. Endpoints used in clinical trials. The design of the studies; blinding, use of control groups, randomization. Regulatory aspects. The Summary of Product Characteristics. Pharmacovigilance and post-authorization studies. Aims of pharmacovigilance. Definitions of adverse drug reaction and adverse event. Severe reactions, unexpected reactions. Classification of adverse reactions by type. Characteristics of type A and B reactions. Immune-mediated hypersensitivity reactions. Idiosyncrasies. Pharmacovigilance: how to identify adverse reactions; criteria of imputability; spontaneous reports. The Risk Management Plan. Active pharmacovigilance: pharmacoepidemiology studies, PASS studies.
Prerequisites
Essential prerequisites: knowledge of physiology, biochemistry, pharmacology.
Books
Lecture slides
Frequency
Attendance is not mandatory but strongly recommended
Exam mode
In the oral exam, the student is asked questions in order to assess the acquisition of the expected learning outcomes. The ability to make connections between the different aspects of the program will be assessed with particular attention. Students also have the opportunity to complete a part of the exam by carrying out a project (for example, the clinical development project of a new drug), to be agreed with the teacher. During the execution of the project, 3-5 meetings with the teacher are held, during which the progress of the project is critically discussed.
Bibliography
Biological Drug Products: Development and Strategies 1st Edition by Wei Wang (Editor), Manmohan Singh (Editor)
Lesson mode
Frontal lessons
  • Academic year2025/2026
  • CoursePharmaceutical Biotechnology
  • CurriculumSingle curriculum
  • Year2nd year
  • Semester1st semester
  • SSDBIO/14
  • CFU6